INmune Bio, Inc., a clinical-stage biotechnology company focused on reprogramming the innate immune system, reported a net loss of $45.9 million for the fiscal year ending December 31, 2025, compared to a loss of $42.1 million in 2024. The company recognized $50,000 in revenue from a license agreement in 2025, a significant increase from the $14,000 reported in the previous year. As of December 31, 2025, INmune Bio had cash and cash equivalents of $24.8 million, reflecting a slight increase from $20.9 million in 2024. The company continues to face substantial doubt about its ability to continue as a going concern, primarily due to ongoing losses and the need for additional capital to fund operations.

The company’s primary focus is on its lead program, CORDStrom, which is aimed at treating Recessive Dystrophic Epidermolysis Bullosa (RDEB). INmune Bio has completed a pivotal, blinded, randomized crossover trial for CORDStrom and plans to file a Marketing Authorization Application (MAA) in the UK and EU in 2026, followed by a Biologics License Application (BLA) with the FDA. Additionally, the company is advancing its XPro1595 platform for Alzheimer’s disease and the INKmune program for metastatic castrate-resistant prostate cancer, with ongoing clinical trials for both.

Research and development expenses decreased to $20.7 million in 2025 from $33.2 million in 2024, primarily due to the completion of the Phase II trial for XPro1595. The company also recorded a $16.5 million impairment of acquired in-process research and development intangible assets related to XPro, which failed to meet its primary endpoint in the trial. General and administrative expenses increased to $10.3 million, driven by higher stock-based compensation.

INmune Bio's workforce consisted of 21 full-time employees as of December 31, 2025, with operations primarily based in the United States and the UK. The company is actively seeking additional funding through equity or debt financing, collaborations, and licensing arrangements to support its ongoing research and development efforts. The financial outlook remains uncertain, with the company projecting continued losses as it advances its clinical programs and seeks regulatory approvals.

About Inmune Bio, Inc.

INmune Bio Inc. develops immunotherapies targeting innate immune dysfunction to treat cancer, neurodegenerative, and inflammatory diseases. Its core platforms include INKmune, an NK cell-based cancer therapy; XPro1595, a TNF inhibitor for Alzheimer's and neuroinflammation; and CORDStrom, a stem cell product for skin disorders. The company focuses on innovative biologics, regulatory pathways, and strategic collaborations to address unmet medical needs in global markets.

This description was generated via AI from an annual report. Updated 8 months ago.

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